NCT04281004

Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)

A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.

Detailed description

Photorefractive Keratectomy (PRK) is a common elective surgery used to correct refractive errors. We propose that amniotic fluid drops may be beneficial in promoting ocular surface healing following PRK. Purified amniotic fluid (pAF) contains anti-inflammatory, anti-microbial and regenerative factors similar to solid amniotic membrane. Individual patients will be randomized to one of two post-operative drop regimens, control eyes that will receive placebo saline solution (NaCl 0.9%, Baxter Medical), and study eyes that will receive pAF four times daily for seven days. This is a randomized, double-masked, placebo-controlled study to determine * the safety of pAF in patients who undergo PRK * if pAF hastens re-epithelialization following PRK compared to placebo * if pAF reduces post-operative pain following PRK compared to placebo * if pAF affects visual outcome following PRK compared to placebo * if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo

Conditions

• Photorefractive Keratectomy

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic Fluid (AFED)	One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
OTHER	Saline Solution	One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days

Timeline

• Start date: 2020-07-10
• Primary completion: 2023-01-16
• Completion: 2023-01-16
• First posted: 2020-02-21
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study